FDA 510(k) Searchable Database - Search 174,000+ Clearances

Search 174,000+ FDA 510(k) clearances by K-number, device name, manufacturer or product code — with real review time data, denied submission rates and regulatory intelligence no other searchable 510(k) database provides.

175,450 clearances · 1976 to present · Updated monthly from FDA records

Filters: Cleared only ×
174,955 results
80977–81000 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Sep 11, 2000
PROLITE VL PULSED LIGHT SYSTEM
K002072 · GEX
Medical Bio Care Sweden AB
General & Plastic Surgery · 66d
Cleared Sep 11, 2000
GOLDEN-RULE SCALING CATHETER
K002416 · DQO
Medical Device Technologies, Inc.
Cardiovascular · 34d
Cleared Sep 11, 2000
LATEX EXAMINATION GLOVES, POWDERED, (CONTAINS 100 MICROGRAMS OR LESS OF TOTAL...
K002448 · LYY
Oon Corp. Resources
General Hospital · 33d
Cleared Sep 11, 2000
FETALTROL
K002511 · JPK
Trillium Diagnostics, LLC
Hematology · 27d
Cleared Sep 11, 2000
DIGITAL BLOOD PRESSURE MONITOR, MODELS HD-503 AND HD-505
K002722 · DXN
Jawon Medical Co., Ltd.
Cardiovascular · 11d
Cleared Sep 11, 2000
INFUSOR PATIENT CONTROL MODULE, 2ML, MODEL 2C1067K
K002739 · MEA
Baxter Healthcare Corp
General Hospital · 10d
Cleared Sep 08, 2000
VITALOGRAPH BASE STATION
K000599 · BZG
Vitalograph, Inc.
Anesthesiology · 199d
Cleared Sep 08, 2000
RESPIRONICS SILHOUETTE NASAL MASK, MODELS 1003224 AND 1003223
K000705 · BZD
Respironics, Inc.
Anesthesiology · 190d
Cleared Sep 08, 2000
HEARTSTREAM XL DEFIBRILLATOR/MONITOR, MODEL M4735A
K001725 · MKJ
Agilent Technologies, Inc.
Cardiovascular · 94d
Cleared Sep 08, 2000
OLYMPUS XGIF-N200H GASTROINTESTINAL VIDEOSCOPE
K001766 · FDS
Olympus Optical Co., Ltd.
Gastroenterology & Urology · 88d
Cleared Sep 08, 2000
PRIMED PLEATED TIE-BACK, PROCEDURE MASK PM4-305, PRIMED PLEATED EAR-LOOP,...
K001951 · FXX
Primeline Medical Products, Inc.
General Hospital · 73d
Cleared Sep 08, 2000
SPIROXCARD DIAGNOSTIC SPIROMETER AND PULSE OXIMETER
K001995 · DQA
Qrs Diagnostic, LLC
Anesthesiology · 70d
Cleared Sep 08, 2000
TAMPAX SATIN TAMPONS, CLOSED END FLUSHABLE APPLICATOR
K002096 · HEB
Procter & Gamble Co.
Obstetrics & Gynecology · 59d
Cleared Sep 08, 2000
RUBBERCARE POLYMER-COATED POWDERED LATEX EXAMINATION GLOVES/GUARDIAN...
K002111 · LYY
Perusahaan Pelindung Getah (M) Sdn Bhd
General Hospital · 58d
Cleared Sep 08, 2000
SUPER 3
K002299 · EJH
Dental Alloy Products, Inc.
Dental · 42d
Cleared Sep 08, 2000
SUPER 12
K002301 · EJH
Dental Alloy Products, Inc.
Dental · 42d
Cleared Sep 08, 2000
SPECTRUM 2 REUSABLE FULL FACE MASK, MODEL 1004884 AND 1004876
K002465 · BZD
Respironics, Inc.
Anesthesiology · 28d
Cleared Sep 08, 2000
M2424A SONOS 5500/4500 DIAGNOSTIC ULTRASOUND SYSTEM, VERSION B.2. 21330A...
K002470 · IYN
Agilent Technologies, Inc.
Radiology · 28d
Cleared Sep 08, 2000
MASIMO SET RADICAL PULSE OXIMETER WITH SATSHARE AND LNOP SERIES OF SENSORS...
K002477 · DQA
Masimo Corp.
Anesthesiology · 28d
Cleared Sep 08, 2000
DERMAGRIP POWDERFREE POLYMER COATED LATEX EXAMINATION GLOVE WITH PROTEIN...
K002579 · LYY
Wrp Specialty Products Sdn. Bhd.
General Hospital · 21d
Cleared Sep 07, 2000
INPLANT ORTHODONTIC ANCHOR SYSTEM
K000643 · DZE
Nobel Biocare Uas, Inc.
Dental · 195d
Cleared Sep 07, 2000
CANNULATION TOURNIQUET SET, 2 TUBE OR 5 TUBE
K000830 · DWF
California Medical Laboratories, Inc.
Cardiovascular · 177d
Cleared Sep 07, 2000
ZORTRAN DETECTOR
K000997 · FOZ
Lucent Medical Systems
General Hospital · 163d
Cleared Sep 07, 2000
P.O.P. PAIN KIT
K001342 · MEB
Post Operative Pain Management
General Hospital · 133d